Trials / Active Not Recruiting
Active Not RecruitingNCT03441971
Evaluation of the GORE PV1 Device in Patients With Pulmonary Valve Dysfunction
Evaluation of the GORE PV1 Device for Replacement of the Pulmonary Valve and Reconstruction of Right Ventricular Outflow Tract
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- Sponsor
- W.L.Gore & Associates · Industry
- Sex
- All
- Age
- 5 Years
- Healthy volunteers
- Not accepted
Summary
This study will assess the safety and performance of the GORE PV1 Device for replacement of the pulmonary valve and reconstruction of the Right Ventricular Outflow Tract (RVOT).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | GORE PV1 | Implantation of GORE PV1 Device for procedure to replace the pulmonary valve and reconstruct the right ventricular outflow tract (RVOT). |
Timeline
- Start date
- 2018-06-07
- Primary completion
- 2020-04-13
- Completion
- 2030-03-01
- First posted
- 2018-02-22
- Last updated
- 2026-02-05
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03441971. Inclusion in this directory is not an endorsement.